Biomarkers of Dietary Intake and Exposure (U2C Clinical Trial Required) | RFA DK 20 005

Opportunity Information: Apply for RFA DK 20 005

The National Institutes of Health (NIH) funding opportunity titled "Biomarkers of Dietary Intake and Exposure (U2C Clinical Trial Required)" (RFA-DK-20-005) is a discretionary grant program offered as a cooperative agreement (U2C mechanism) in the areas of food, nutrition, and health (CFDA 93.847). Its central goal is to bring together multidisciplinary research teams to create new, metabolomics-based biomarkers that can objectively measure dietary intake and exposure, and then rigorously validate those candidate biomarkers against existing "gold standard" or benchmark dietary biomarkers as well as established dietary assessment methods (for example, traditional self-report tools and related approaches). Because this is a "Clinical Trial Required" announcement, the work is expected to involve prospective human research that fits NIH's definition of a clinical trial, consistent with the intent to develop and validate biomarkers in real-world or controlled human settings.

A key emphasis of the announcement is metabolomics, meaning applicants are expected to leverage high-throughput profiling of small molecules in biological specimens (such as blood or urine) to identify chemical signatures that correspond to specific foods, dietary patterns, nutrients, or exposure-related compounds. The intent is not just discovery of potential markers, but careful validation: showing that the metabolomics-derived measures agree with current benchmark biomarkers where available, and demonstrating how these measures perform compared to common dietary assessment approaches. In practice, this kind of work typically involves controlled feeding studies, observational cohorts with strong dietary assessment infrastructure, repeated biospecimen collection, and robust analytical and statistical pipelines to evaluate sensitivity, specificity, reproducibility, dose-response, and performance across populations and contexts.

The award uses a cooperative agreement structure, which generally means NIH expects to have substantial programmatic involvement during the project period. Compared with a standard research project grant, a U2C often implies closer coordination with NIH scientific staff, potential milestone-based management, and an expectation that the project operates as part of a broader, coordinated effort. Applicants should be prepared for collaborative planning, data harmonization expectations, and active engagement with NIH regarding study design choices and progress toward agreed-upon objectives.

Eligibility is broad and includes many types of domestic U.S. organizations: state, county, city, and township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other tribal organizations (not federally recognized); public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education when specified in the listing); for-profit organizations other than small businesses; small businesses; and other eligible entities. The announcement also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, it draws a clear boundary around foreign participation: non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply as the applicant organization. However, "foreign components" as defined by the NIH Grants Policy Statement are allowed, meaning a U.S.-based applicant may include certain international elements or collaborations when they meet NIH requirements for foreign components.

The opportunity was created on July 2, 2020, with an original closing date of October 21, 2020. The public listing does not provide an award ceiling or the expected number of awards in the fields shown, so applicants would typically need to consult the full FOA text and any NIH notices for budget limits, project period expectations, and the anticipated funding level.

Overall, this FOA is aimed at improving the scientific toolkit for nutrition research by moving beyond self-reported diet data alone and strengthening objective measurement of what people eat and what they are exposed to through diet. By focusing on metabolomics-driven biomarkers and requiring validation against benchmarks and established methods, it targets a known bottleneck in nutrition science: accurate, scalable, and reliable assessment of dietary intake and exposure across diverse populations and study designs.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Biomarkers of Dietary Intake and Exposure (U2C Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2020-07-02.
• Applicants must submit their applications by 2020-10-21. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA DK 20 005

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